The Recall Desk

Manufacturer

Abbott Medical Optics, Inc.

9 recalls in our database name Abbott Medical Optics, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
0
Most recent
2015-04-29

Of the 9 recalls from Abbott Medical Optics, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

  • HighFDA (Devices)·Z-1515-2015·2015-04-29

    Abbott OptiMedica Catalys Precision Laser System Recalled for Corneal Scoring Risk

    Abbott Medical Optics is recalling 202 OptiMedica Catalys Precision Laser Systems because loss of suction during cataract surgery may cause corneal scoring.

    Product
    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2014·2013-10-30

    Abbott Recalls STAR Excimer Laser Systems Due to Power Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems because a power component failure can cause the lamp and illumination system to malfunction.

    Product
    STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2014·2013-10-30

    Abbott Medical Optics Recalls STAR Excimer Laser Systems Due to Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor component failure that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2014·2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the AC Power Distribution PCB that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratecto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0046-2014·2013-10-30

    Abbott STAR Excimer Laser Systems Recalled for Thyristor Component Failure

    Abbott Medical Optics is recalling STAR Excimer Laser Systems due to a thyristor failure on the power distribution board that affects the lamp and illumination system.

    Product
    STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratecto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1670-2013·2013-07-17

    Abbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk

    Abbott Medical Optics is recalling 534 Sovereign Compact Phacoemulsification Systems because they may lose vacuum tone mode during cataract surgery.

    Product
    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1541-2013·2013-06-19

    Abbott STAR S4 IR Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2013·2013-06-19

    Abbott STAR S3 Excimer Laser System Recalled for Firing Risk

    Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1540-2013·2013-06-19

    Abbott STAR S4 Excimer Laser System Recalled for Potential Inadvertent Firing

    Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.

    Product
    STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain
    Category
    Medical Device
    Distribution
    Distributed nationwide